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http://dx.doi.org/10.13160/ricns.2011.4.4.315

Investigation of New Drug Submission Documents for the Safety and Efficacy Evaluation of Stereoisomeric Drugs  

Kim, Kwang Joon (College of Pharmacy, Chosun University)
Choi, In (Department of Pharmacy, Chosun University Hospital)
Lee, Beom-Gyu (Department of Chemistry, Chosun University)
Moon, Hong Seop (College of Pharmacy, Mokpo Nationnal University)
Han, Hyo Kyung (College of Pharmacy, Dongguk University)
Choi, Eun Joo (College of Pharmacy, Chosun University)
Lee, Wonjae (College of Pharmacy, Chosun University)
Publication Information
Journal of Integrative Natural Science / v.4, no.4, 2011 , pp. 315-322 More about this Journal
Abstract
This study was performed to investigate the current regulatory guidances of safety and efficacy evaluation for the approval of stereoisomeric drugs in Korea and US. According to the regulatory guidelines in major countries (EU, Canada, US), the important categories for the development of stereoisomeric drugs are classified as 1) development of a single enantiomer as a new active substances 2) development of a racemate as a new active substance 3) development of a new single enantiomer from an approved racemate. For this study, domestic regulatory documents for current guidelines of stereoisomeric drugs were investigated. Also four typical stereoisomeric drugs for three categories were chosen to investigate the new drug submission documents of KFDA and FDA for the safety and efficacy evaluation of stereoisomeric drugs. It is expected that these comparative results between KFDA and FDA will be useful for the safety and efficacy for the regulatory approval of stereoisomeric drugs in Korea.
Keywords
Stereoisomeric Drugs; Regulatory Guideline; Safety; Efficacy;
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Times Cited By KSCI : 1  (Citation Analysis)
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1 C. A. Challener, "Chiral drugs", Aldershot, Ashgate Publishing, pp. 15-25, 2002.
2 L. A. Nguyen, H. He, and C. Pham-Huy, "Chiral drugs, an overview", Int. J. Biomed. Sci., Vol. 2, pp. 85-100, 2006.
3 G. Subramanian, "A practical approach to chiral separations by liquid chromatography", Weinheim, VCH, pp. 63-70, 1994.
4 J. R. Brown, "Regulatory implications and chiral separations, In: A practical approach to chiral separations by liquid chromatography (Ed.: Subramanian, G.)", Weinheim, VCH, pp. 57-62. 1994,
5 J. M. Daniels, E. R. Nestmann, and A. Kerr, "Development of stereoisomeric (chiral) drugs: a brief review of scientific and regulatory considerations", J. Drug Infor., Vol. 31, pp. 639-646, 1997.   DOI
6 N. R. Srinivas, R. H. Barbhaiya, and K. K. Midha, "Enantiomeric drug development: issues, considerations, and regulatory requirements", J. Pharm. Sci., Vol. 90, pp. 1205-1215, 2001.   DOI   ScienceOn
7 I. K. Reddy and R. Mehvar, "Chirality in drug design and development", Marcel Dekker, New York, pp. 419-432, 2004.
8 FDA's policy statement for the development of new stereoisomeric drugs. Chirality, Vol. 4, pp. 338-340, 1992.   DOI   ScienceOn
9 FDA Drug guidances, "Development of new stereoisomeric drugs", July 6, 2005, Internet site : http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122883.htm
10 Investigation of chiral active substances (CPMP/III/ 3501/91). Internet site: http://www.ema.europa.eu/ docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002816.pdf
11 Guidance for Industry : Stereochemical Issues in Chiral Drug Development.Therapeutic Products Programme. Health Canada (May 1, 2000). Internet site: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/ applic-demande/guide-ld/chem/stereo-eng.php
12 FDA Drug guidances: Development of new stereoisomeric drugs. (July 6, 2005), Internet site : http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122883.htm
13 O. C. Sun, H. J. Sung, Y. U. So, J. J. Seo, I. K. Joo, and Y. C. Soo, "tereochemical Issues in Chiral Drug Development", J. Kor. Pharm. Sci., Vol. 35, pp. 57-63, 2005.
14 식품의약품안전청 공고 제 2008 - 82호, "의약품등의 품목허가신고심사규정", May 2, 2008, Internet site: http://kfda.go.kr/index.kfda?mid=54&seq=3742
15 의약품안전국, "K의약품등의 안전성유효성 심사 관련해설서", 식품의약품안전청, 2008.
16 미국 식품의약청 안전청 Internet site: http://www.fda.gov/Drugs/default.htm
17 International Federation of Pharmaceutical Manufactures Associations; IFPMA internet site : www.ifpma.org
18 Q6A International Conference on Harmonisation; Guidance on Q6A International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceutical Human Use, Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products : Chemical Substances, May, 2000, (CPMP/ICH/367/96) internet site: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC 500002823.pdf